Prevalence and Impact of Diabetes Mellitus in Hospitalized COVID-19 Patients in a Tunisian Center

Sponsor
Sana Rouis (Other)
Overall Status
Completed
CT.gov ID
NCT05851820
Collaborator
(none)
866
1
11.2
77.5

Study Details

Study Description

Brief Summary

Objective: The objective of this study was to evaluate the prevalence and impact of diabetes mellitus on the severity and mortality of COVID-19.

Methods: Data of laboratory-confirmed hospitalized patients at the COVID-19 unit of Ibn El Jazzar University Hospital in Kairouan between September 2020 and August 2021 were analysed, in a cross-sectional study. The population was classified into two groups (COVID-19 patients with versus without diabetes). Primary outcomes were the overall length of hospital stay, the admission to the intensive care unit (ICU), and death.

Condition or Disease Intervention/Treatment Phase
  • Other: comparison of outcomes/exposure

Detailed Description

The outbreak of the coronavirus disease 2019 (Covid-19) has become an evolving worldwide health crisis. With the rising prevalence of diabetes mellitus has come an increasing awareness of their impacts on infectious diseases, and the risk for post-infection complications and mortality from critical infections.

Objective: The objective of this study was to evaluate the prevalence and impact of diabetes mellitus on the severity and mortality of COVID-19.

Methods: Data of laboratory-confirmed hospitalized patients at the COVID-19 unit of Ibn El Jazzar University Hospital in Kairouan between September 2020 and August 2021 were analysed, in a cross-sectional study. The population was classified into two groups (COVID-19 patients with versus without diabetes). Primary outcomes were the overall length of hospital stay, the admission to the intensive care unit (ICU), and death. Association between diabetes and death was assessed in a Cox proportional hazards model.

Study Design

Study Type:
Observational
Actual Enrollment :
866 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Prevalence and Impact of Diabetes Mellitus in Hospitalized COVID-19 Patients in a Tunisian Center: a Cross Sectional Study
Actual Study Start Date :
Sep 25, 2020
Actual Primary Completion Date :
Aug 31, 2021
Actual Study Completion Date :
Aug 31, 2021

Arms and Interventions

Arm Intervention/Treatment
diabetic patients with COVID-19

patients hospitalized for COVID-19 and were diabetic

Other: comparison of outcomes/exposure
analysing if diabetes mellitus have an impact on the primary outcomes: hospital stay, admission to the ICU, death.

Non-diabetic patients with COVID-19

patients hospitalized for COVID-19 and were not diabetic

Other: comparison of outcomes/exposure
analysing if diabetes mellitus have an impact on the primary outcomes: hospital stay, admission to the ICU, death.

Outcome Measures

Primary Outcome Measures

  1. Admission to Intensive Care Units [7 days]

    patients who were transferred to ICU

  2. death [7 days]

    patients who were dead

  3. overall length of hospital stay [7 days]

    length of hospital stay from admission to discharge (or transfer or death)

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Confirmed cases indicated the patients whose real-time reverse transcriptase-polymerase chain reaction (RT-PCR) analysis results for nasal swab specimens were positive.

Exclusion Criteria:
  • the investigators didn't included patients who were suspected cases, and whose the result of PCR test was negative ; Covid-19 patients admitted in other departments (Cardiology, pediatrics, obstetrics, intensive care unit, medicine, surgery department…) ; and patients with missing medical records. -

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kairouan Kairouan Tunisia

Sponsors and Collaborators

  • Sana Rouis

Investigators

  • Principal Investigator: sana rouis, MD, Faculty of Medicine, Sousse

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sana Rouis, Assistant professor in Infectious Diseases, Faculty of Medicine, Sousse
ClinicalTrials.gov Identifier:
NCT05851820
Other Study ID Numbers:
  • SRouis
First Posted:
May 10, 2023
Last Update Posted:
May 10, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sana Rouis, Assistant professor in Infectious Diseases, Faculty of Medicine, Sousse
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 10, 2023